Excimer Light for Alopecia Areata

NCT ID: NCT01802177

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28

Brief Summary

Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.

Detailed Description

Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease.

Excimer laser has been shown to be effective in the treatment of AA in controlled studies. The main disadvantage of the previous studies evaluating excimer laser is choosing separate patches as a control which does not account for interlesional treatment response variability. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. However, there are only a few studies that evaluated the efficacy and safety of UVB excimer light in AA. Those studies have shown that UVB excimer light is effective in the treatment of AA but none of them was conducted in a controlled fashion.

There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.

Study Objectives

1. To evaluate the potential for UVB excimer light to induce hair regrowth within AA patches.

2. To assess the side effect profile of UVB excimer light when used in the treatment of AA.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

UVB excimer light

Patches of alopecia will be treated twice weekly with UVB excimer light. Only one half of a single alopecia areata patch will be treated. In order to treat the same half during each visit, a transparent sheet will be marked, using a marking pen, to delineate the borders of the treatment area with a central dividing line. The other half will be covered and used as a control. Treatments will be given randomly (by sealed envelope randomization method) into one of the two halves in different patients but will be given into the same half in each patient in all treatment sessions. Only one investigator will know the intervention each half has received. A total of 23 treatments will be given over 12 weeks.

Group Type: EXPERIMENTAL

UVB excimer light

Intervention Type: PROCEDURE

No treatment (covered)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

UVB excimer light

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years.
• Subject has a patch of at least 12 cm2 on the scalp with no evidence of hair regrowth.
• Subject is willing and capable of cooperating to the extent and degree required by the protocol.

Exclusion Criteria

• Patients who received treatment for alopecia areata within the past 4 weeks.
• Patients with alopecia totalis or alopecia universalis.
• Patients with known photosensitivity like having polymorphous light eruption, connective tissue diseases, porphyria or Xeroderma pigmentosum.
• Pregnancy or breast-feeding.
• History of previous skin cancer.
• Patients that have participated in another investigational drug or device study within 30 days of enrollment.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harvey Lui, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

The Skin Care Center, Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Harvey Lui, MD, FRCPC

Role: CONTACT

harvey.lui@ubc.ca

16048754111

Facility Contacts

Harvey Lui, MD FRCPC

Role: primary

harvey.lui@ubc.ca

16048754111 ext. 68691

Other Identifiers

H12-02840

Identifier Type: -

Identifier Source: org_study_id